An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.

NCT00420056 ↗

Phase 1 Completed 17 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.

Timeline

Start: 2007-05
Primary completion: 2010-03
Completion: 2012-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); PD 0332991; p = 0.4854; Regression, Linear NCT00420056 ↗

registry analysis (superiority or other test); PD 0332991; p = 0.7090; Regression, Linear NCT00420056 ↗

registry Kappa 0.0638 (95% CI -0.0449 to 0.1726) NCT00420056 ↗

registry Kappa 0.1864 (95% CI -0.2316 to 0.6045) NCT00420056 ↗

Publications

Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palbociclib	Small molecule	125 mg	Oral